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Z-2573-2018 Class III Terminated

Recalled by Diamedix Corporation — Miami Lakes, FL

FDA device recall Z-2573-2018 was initiated by Diamedix Corporation on January 5, 2018 and is designated Class III. Reason for recall: Contains a gel-like contaminant that may affect product performance. The recall status is terminated (terminated November 5, 2019). Affected quantity: 505.

Recall Details

Product Type: Devices
Report Date: August 8, 2018
Initiation Date: January 5, 2018
Termination Date: November 5, 2019
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 505

Product Description

Diamedix Is-Mumps IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic Use Catalog No. 720-540

Reason for Recall

Contains a gel-like contaminant that may affect product performance.

Distribution Pattern

AZ, CA, FL, IL, IN, KY, MA, MI, MN, MO, NH, NJ, NY, OH, OK, PA, RI, TN, TX, and WI

Code Information

Lot S0406 Exp. 05/31/2018

Other recalls by Diamedix Corporation

Z-2574-2018 Class III — Diamedix Is-EBV-EA-D IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic Use (January 5, 2018)
Z-1689-2016 Class II — Diamedix Is-CMV IgG Test Kit (March 26, 2015)
Z-1687-2016 Class II — Diamedix Is-EBV-EA-D IgG Test Kit Diamedix Is-Mumps IgG Test Kit is an EIA p (October 20, 2014)
Z-1686-2016 Class II — Diamedix Is-EBV-VCA IgG Test Kit Diamedix Is-Mumps IgG Test Kit is an EIA pr (October 20, 2014)
Z-1685-2016 Class II — Diamedix Is-Mumps IgG Test Kit Diamedix Is-Mumps IgG Test Kit is an EIA proc (October 20, 2014)
Z-0445-2013 Class II — The Is-anti-Sm test kits****Catalog No: 720-240*** Product Usage: The Diamedix (August 6, 2012)